Acalabrutinib - Generic Drug Details

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What are the generic sources for acalabrutinib and what is the scope of patent protection?

Acalabrutinib is the generic ingredient in one branded drug marketed by Astrazeneca and is included in two NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acalabrutinib has one hundred and eighty-three patent family members in forty-nine countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for acalabrutinib

International Patents:	183
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	137
Patent Applications:	1,237
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for acalabrutinib
What excipients (inactive ingredients) are in acalabrutinib?	acalabrutinib excipients list
DailyMed Link:	acalabrutinib at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for acalabrutinib

Generic Entry Date for acalabrutinib^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for acalabrutinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mayur Narkhede	Phase 1
ADC Therapeutics S.A.	Phase 1
Merck Sharp & Dohme LLC	Phase 3

See all acalabrutinib clinical trials

Generic filers with tentative approvals for ACALABRUTINIB

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	100MG	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for acalabrutinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for acalabrutinib

L01EL	Bruton's tyrosine kinase (BTK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for ACALABRUTINIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CALQUENCE	Capsules	acalabrutinib	100 mg	210259	5	2021-11-01

US Patents and Regulatory Information for acalabrutinib

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for acalabrutinib

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AstraZeneca AB	Calquence	acalabrutinib	EMEA/H/C/005299 Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.	Authorised	no	no	no	2020-11-05
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for acalabrutinib

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Country	Patent Number	Title	Estimated Expiration
Japan	2022088618	ＢＴＫ阻害剤としての４－イミダゾピリダジン－１－イル－ベンズアミドおよび４－イミダゾトリアジン－１－イル－ベンズアミド	⤷ Sign Up
Japan	4916883		⤷ Sign Up
Morocco	50817	FORMES ET FORMULATIONS SOLIDES DE (S)-4-(8-AMINO-3-(1-(BUT-2-YNOYL)PYRROLIDIN-2-YL)IMIDAZO[1,5-A]PYRAZIN-1-YL)-N-(PYRIDIN-2-YL)BENZAMIDE	⤷ Sign Up
Israel	230511	(s)-4-(8-אמינו-3-(1-בוט-2-ינוייל-פירולידינ-2-יל)אימידאזו[5,1-a]פיראזינ-1-יל)-n-(פירידינ-2-יל)בנזאמיד כמעכב btk ((s)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-n-(pyridin-2-yl)benzamide as btk-inhibitor)	⤷ Sign Up
Turkey	201901013		⤷ Sign Up
Russian Federation	2018103913	ТВЕРДЫЕ ФОРМЫ И КОМПОЗИЦИИ (S)-4-(8-АМИНО-3-(1-(БУТ-2- ИНОИЛ)ПИРРОЛИДИН-2-ИЛ)ИМИДАЗО[1,5-A]ПИРАЗИН-1-ИЛ)-N-(ПИРИДИН-2-ИЛ)БЕНЗАМИДА	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for acalabrutinib

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2734522	12/2021	Austria	⤷ Sign Up	PRODUCT NAME: 4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDE UND 4-IMIDAZOTRIAZIN-1-YL-BENZAMIDE ALS BTK-INHIBITOREN; REGISTRATION NO/DATE: EU/1/20/1479 (MITTEILUNG) 20201106
2734522	122021000020	Germany	⤷ Sign Up	PRODUCT NAME: ACALABRUTINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1479 20201105
2734522	21C1014	France	⤷ Sign Up	PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/20/1479 20201106
2734522	C20210006 00368	Estonia	⤷ Sign Up	PRODUCT NAME: AKALABRUTINIIB;REG NO/DATE: EU/1/20/1479 06.11.2020
2734522	2021016	Norway	⤷ Sign Up	PRODUCT NAME: AKALABRUTINIB; REG. NO/DATE: EU/1/20/1479 20201111
2734522	2021C/512	Belgium	⤷ Sign Up	PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.